A Study Assessing KB407 for the Treatment of Cystic Fibrosis

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Krystal Biotech, Inc.
Study ID
NCT05504837
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KB407 (Nebulization) — BIOLOGICAL
    Nebulized solution of KB407, a replication-defective HSV-1 expressing full length human CFTR

Study Details

This study will evaluate safety and tolerability of ascending doses of nebulized KB407 in adults with cystic fibrosis.

Key Dates

Start date
Jun 30, 2023
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (open label)
    A single administration of KB407
  • Experimental: Cohort 2 (open label)
    Two administrations of KB407
  • Experimental: Cohort 3 (open label)
    Four administrations of KB407
  • Experimental: Cohort 4 (open label)
    Four consecutive administrations of KB407 followed by weekly administration for up to 6 months

Primary Outcome Measure

To evaluate safety and tolerability of KB407 based upon assessment of adverse events (frequency, severity, relatedness), and changes from baseline in physical examinations, vital signs, ECG, and clinical laboratory test results [ Time Frame: 6 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of Florida, GainesvilleGainesvilleFlorida32610
Alexa Smith
[email protected]
352-273-5085
Jorge Lascano, MD (PRINCIPAL_INVESTIGATOR)
St. Lukes CF Center of IdahoBoiseIdaho83712
Dixie Durham
[email protected]
208-381-7092
Karen Miller, MD (PRINCIPAL_INVESTIGATOR)
The Cystic Fibrosis InstituteNorthfieldIllinois60093
Karolina Roszko
[email protected]
Steven Boas, MD (PRINCIPAL_INVESTIGATOR)
New York Medical College/ Boston Children's Health PhysiciansHawthorneNew York10532
Armando Ramirez, CRC
[email protected]
914-504-0152
John Welter, MD (PRINCIPAL_INVESTIGATOR)
Northwell Health PhysiciansNew YorkNew York10028
Teresa Demarco
[email protected]
212-434-4790
Maria Berdella, MD (PRINCIPAL_INVESTIGATOR)
Atrium Health Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157
Christian Smith
[email protected]
336-173-8550
Chad R Marion, DO, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gainesville, FL

By research site
University of Florida, Gainesville· Gainesville, FLSt. Lukes CF Center of Idaho· Boise, IDThe Cystic Fibrosis Institute· Northfield, ILNew York Medical College/ Boston Children's Health Physicians· Hawthorne, NYNorthwell Health Physicians· New York, NYAtrium Health Wake Forest Baptist Medical Center· Winston-Salem, NC

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